Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trivalent Influenza Vaccine 1 SP Shz TIV1 · 1 trial · 1 indication
Geometric mean titers will be assessed by a hemagglutination (HAI) method
Influenza antibodies will be assessed using the HAI method.
Geometric mean titers will be assessed by a HAI method
Influenza antibodies will be assessed using the HAI method.
Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged \<= 23 months and fever, headache, malaise, myalgia and shivering for participants aged \> 2 years.
Adverse events other than solicited reactions
Serious adverse events (including adverse event of special interest) are assessed throughout the study.
| Arm | Type | Description |
|---|---|---|
| Group A: 6 to 35 months, previously unvaccinated, step 1 | EXPERIMENTAL | Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28 |
| Group 1: 6 to 35 months, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 2: 3 to 8 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| Group 3: 9 to 17 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 4: 18 to 60 years, step 2 | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Group 5: >=61 years | EXPERIMENTAL | Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 1 SP Shz TIV1 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
| Trivalent Influenza Vaccine 2 SP Shz TIV2 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: intramuscular |
Inclusion criteria : * Aged ≥ 6 months on the day of the first study visit/inclusion * In good health or with underlying medical condition(s) that are judged to be stable by the investigator. Medically-stable is defined as: * No new diagnosis OR * No new class of prescription drug initiated du...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
Trivalent Influenza Vaccine 1 SP Shz TIV1 is an investigational vaccine developed by Sanofi for the prevention of influenza. It is a trivalent inactivated influenza vaccine candidate that has been studied in a Phase 3 clinical trial conducted in China in subjects from 6 months of age.
Trivalent Influenza Vaccine 1 SP Shz TIV1 is being developed for the prevention of influenza, an infectious disease. Its clinical program has focused on immunization of healthy volunteers, including young children from 6 months of age, against seasonal influenza.
Trivalent Influenza Vaccine 1 SP Shz TIV1 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this trivalent inactivated influenza vaccine candidate.
Trivalent Influenza Vaccine 1 SP Shz TIV1 is in Phase 3 development. It is an investigational vaccine candidate and is not described as approved. The Phase 3 trial evaluating it has been completed, and no trials for this candidate are currently listed as active.
Trivalent Influenza Vaccine 1 SP Shz TIV1 was evaluated in the Phase 3 trial NCT04210349, titled Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age. The trial enrolled 7,106 participants in China and has been completed.
The Phase 3 trial NCT04210349 was a randomized, double-blind, controlled study of Trivalent Influenza Vaccine 1 SP Shz TIV1 in Chinese subjects from 6 months of age. It enrolled 7,106 healthy volunteers of all sexes and compared the trivalent inactivated influenza vaccine against a quadrivalent inactivated influenza vaccine.